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Major Depressive Disorder | Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

Major Depressive Disorder research study

What is the primary objective of this study?

The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis

Who is eligible to participate?

Inclusion Criteria: - Age: 16-65 years old - Signed informed consent by patient or legal representative - Hamilton Rating Scale for Depression (HDRS) scores ≥ 16 - A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry Exclusion Criteria: - Monoamine oxidase inhibitor or antidepressant treatment prior to entering the study - A DSM-IV diagnosis of substance abuse within the past three months - An organic mental disease, mental retardation or dementia - A serious surgical condition or physical illness - Patients who were pregnant or breastfeeding

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fluoxetine + ValsartanThe curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.

Drug:Fluoxetine + PlaceboThe curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fluoxetine + ValsartanThe initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg. Add-on treatment to 40 mg per day of valsartan

Fluoxetine + PlaceboThe initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg. Add-on treatment to placebo

Study Status

Unknown status

Start Date: August 2012

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Hamilton Depression Rating Scale (HDRS)

Secondary Outcome: fasting plasma glucose

Study sponsors, principal investigator, and references

Principal Investigator: Po See Chen, M.D., Ph.D

Lead Sponsor: National Cheng-Kung University Hospital

Collaborator: National Science Council, Taiwan

More information:https://clinicaltrials.gov/show/NCT01699490

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